This presentation will describe different PK assays that are required to support preclinical toxicology studies, and the challenges involved in the developing multiple assays in several species’ matrices. Standardizing the lower limit of quantitation (LLOQ) requirements across ADC programs with similar molecular weights (≥150K) and dose regimens, would accelerate bioanalytical method development without waiting for toxicology/PK input, minimize rework due to LLOQ uncertainty, and facilitate rapid method transfers and validations.
A potential 2-in-1 combination assay for both tADC and tAb would further simplify ADC bioanalytical method development. This approach will also consider the limited sample volumes available for rat or mouse toxicology studies. We will discuss the advantages and disadvantages of these simplified strategies, along with relevant case studies.
Learning Objectives:
List the number of bioanalytical assays required for ADC development
Understand the challenges involved in the ADC assay development and how to mitigate these issues with the streamlined bioanalytical strategy
Learn about novel 2-in-1 hybrid LC/MS assay that quantify both ADC and total Ab in a single sample
